Spots Global Cancer Trial Database for Dose-Finding and Safety Study for Oral Single-Agent to Treat Advanced Malignancies

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Trial Identification

Brief Title: Dose-Finding and Safety Study for Oral Single-Agent to Treat Advanced Malignancies

Official Title: A Phase 1, Open-Label, Dose-Ranging, Safety and Pharmacokinetic Study to Determine the Maximum Tolerated Dose of RX-3117 Administered Orally as a Single-Agent to Subjects With Advanced Malignancies

Study ID: NCT02030067

Conditions

Solid Tumor

Metastatic Bladder Cancer

Interventions

RX-3117

Study Description

Brief Summary: The purpose of this study is to determine the maximum tolerated dose of RX-3117 in subjects with advanced or metastatic solid tumors (Phase 1). The purpose of the Phase 2 portion is to estimate anti-tumor activity in subjects with advanced malignancies (relapsed or refractory pancreatic or advanced bladder cancer).

Detailed Description: This is a dose-finding, open-label, single agent study of RX-3117. Once the maximum tolerated dose is identified additional subjects will be treated in a dose expansion followed by a 2-stage Phase 2 study. Subjects will be treated for up to 8 cycles of therapy. A cycle will be 4 weeks. RX-3117 dosing will be 3 times each week for 3 weeks follow by 1 week off treatment. All subjects will be followed for at least 30 days after the last dose of RX-3117.